Why people may not be eligible to join a trial

All trials have guidelines about who can take part. These are called eligibility criteria. Eligibility criteria are used to ensure that trials include the sort of people who may benefit from the treatment, and to make sure that people who take part are not exposed to avoidable risks. Inclusion criteria help the researchers to decide who can take part in the trial. Some trials only include people in a certain age group, or of one sex, or at a particular stage of their illness. The exclusion criteria state who cannottake part in the trial. For example, people who are already taking particular medicines may be excluded as these may affect the trial treatment. (See Resources for more information).

For some people, being told they do not meet the eligibility criteria can be good news for their own health.

Sabiha is a medical secretary and a counsellor. She has 2 children aged 26 and 17. Ethnic background/nationality' Pakistani.

I read a paper, and in it had an article if anybody wanted to take part in a trial, and I thought, “I don’t mind”, because I was told by my consultant that there was, my - as I’m diabetic, my cholesterol levels should be lower than a normal person, and that I might have to be put on a medication called statin. And so I thought it would be a good thing to find out whether it would benefit me as well as anybody else.

So what did it say in the, in the thing in the newspaper about what the trial was looking for?

Well, they just said that there was a trial for cholesterol, and if anybody was to take part, to ring in, which I did. And I was to have my bloods done, and it depended on my bloods if that’s what they were looking for, the level that they wanted for the trial. And I said, “Yes, I would be interested” and I did have my bloods done. Good for me that my blood, my cholesterol level was not that high, but it wasn’t what they were looking for. So I did not have to go any further. But I was ready to take part. But it wasn’t for what they were looking for.

Were you disappointed by that?

Well, in a way I was disappointed. Not from the point of view of my health, because that was good for me, but from their point of view, that I couldn’t be of any help.

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Profile Info

Age at interview:

68

Sex:

Male

Background:

Charles is a retired chief engineer. He is married with 5 adult children. Ethnic background/nationality' White British.

I believe I first heard - I mean we’re going back to 2004 - from the local surgery, my doctor, and it was just sending through presumably a circular that they had received asking for volunteers for a certain testing that this particular company wanted to carry out. And I just took it up, because they said that if you wanted to, phone a certain number. So I phoned that number and they identified one or two areas that they were interested in having volunteers. And the one which I was interested in at the time, because there was a lot of publicity about it, was prostate cancer testing, advanced testing, and they wanted to trial some new in inverted commas cures that they had. And there was a phone call, then an appointment, and then a number of visits, the last one being where they took tests, blood tests, basically associated with a fairly basic medical, and then you waited and then ultimately you got a result back. And in my particular case the measurement that came back from the blood tests was below the level which they were after to conduct their further research, because I fell into the category which would have been negative as far as they were concerned. So I didn’t go forward to actually taking whatever they were prescribing whether it was pills or drugs I don’t know. So that was the end of it.

How did you feel about that at that particular point?

Oh, I felt very pleased, because although people kept this very to themselves, I’m fairly certain my father suffered from prostate problems. He never called it cancer but I would suspect it might have been. And therefore, you know, you were aware that that was a possibility, and therefore if I could eliminate that, that would be a benefit.

Sarah was more disappointed to find she was not eligible for a trial because she did not meet one of the inclusion criteria. She felt this was something her doctor should have realised earlier.

There are a few, a few other things that I’d quite like to ask about. I mean one is from your experience of that, how you would feel now about going into another trial, whether you’d volunteer again?

Not for an invasive one I wouldn’t. Definitely not injections. Anything else I don’t mind [laughs]. Tablets, yes. I did actually start another one with -because I’ve got very high cholesterol - it was a trial for lipids, because I’ve got familial mixed hyperlipidaemia, and they can’t get my lipids and my cholesterol balancing. But unfortunately, I was on it for a couple of weeks and then I was called back to say that the drug company didn’t want me after all because of the, I wasn’t actually on statins, I was taking some – what was it? cipra?* Anyway the tablets I am taking aren’t statins, and they wanted somebody on statins.

How did you feel about that? Were you disappointed about that?

Yes, I was, because he said, the doctor had said “Oh, people who use this definitely lose some weight, and it’s under guaranteed that your cholesterol will go down even further” - even further, it’s still quite high, but further [laughs]. And yes, I was very disappointed about that one, because I thought, “Miracle drug, it’s going to help,” [laughs].

I mean that is something that presumably they could have found out before you’d got that far down the --

Yes, because he was really excited looking at the check list saying “Yes, yes, yes, you qualify for all of this”, and then go back in embarrassment, was not needed after all [laughs].

* Ciprofibrate (brand name Modalim)

Charles was also disappointed to discover he was excluded from a trial because he had turned 66 in between the first and second appointments. He felt it was an avoidable mistake and was not well handled. Not only did the researchers lose a volunteer for that study, but it has also made him a bit more reluctant to volunteer again. However, he said he did not want others to be put off by his experience.

Charles is a retired chief engineer. He is married with 5 adult children. Ethnic background/nationality' White British.

And I suppose in 2006 they sent through something on - I have to look at my list, [laughs] what do they call it now - erectile dysfunction, which I was obviously fairly interested in bearing in mind my age. And so I rang in again and yes, they were interested, and I mean it was a very simple sort of yes/no telephone conversation at that stage. And so in this particular case they called you in for the first interview. And the first interview was again fairly - well in my, in this particular case the phone call that I originally had was the latter part of 2005, but then for various reasons, nothing to do with me but to do with I think the funding for the scheme that they were doing, they postponed it for a few months. And they contacted me in sort of March time 2006, and so the first interview took place on, in early April 2006. At that stage I was sixty-five.

Now the test, or the funding that they’d got was for research into the age group of fifty-five to sixty-five, and I clarified this at the time and they said, “Yeah, no problem at all, sixty-five is fine.” And so I went through that first test. Now I thought that I would be enrolled at that point in time on their scheme, which if you were involved a number of visits, probably lasting over six months or may even be more. So it was not a sort of a once off visit, it was a continuing sort of trial. So I passed the first one - [laughs] if you pass anything - and then I went back for the second one, which happened to be on the 19th of April. That date is important because my birthday is the 8th of April, and that is when I passed from sixty-five to sixty-six. No comment from them when I went back on the 19th, or even previous -because they had all my particulars as far as my birthday was concerned. So I went back, and this was far more, it was fairly lengthy, actually. I suppose it was about a two-hour visit with little waits in between, because you saw various people, and you went through, not an exhaustive but a fairly comprehensive medical, where they tested all the normal things, you know, blood pressure, heart rate and listened to various things, ultimately ending up with a blood test or taking blood samples.

And you had an interview at that stage with a doctor who explained the purpose of this particular trial, how it would be carried out etcetera, and it sounded quite interesting, because they were exploring a, an inhaler variety, rather than taking a pill like Viagra or something else, they were exploring I suppose something like - they showed me actually - it looked like a normal asthma inhaler and which was meant to have more or less an immediate result, because it went straight into your system and they were very hopeful at the time that it would get over the problems which most pills have where there is a length of time between them [laughs] being taken and working, if they work. And by that time you may not want to or may not feel the, the moment has passed.

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Profile Info

Age at interview:

68

Sex:

Male

Background:

Charles is a retired chief engineer. He is married with 5 adult children. Ethnic background/nationality' White British.

But what happened was that at the very end of my visit on this fairly lengthy, you had a sort of a clear up session where I signed the forms and consent form, and they pointed, someone noticed - it was actually not the doctor, it was an admin secretary - that I was now sixty-five, sixty-six rather, and the trial was to sixty-five. And so they went into a huddle, not in my presence, and they basically said due to which they felt - and they may have been correct - problems with funding that they might have, they felt that they couldn’t enrol me on the trial.

Now having gone through, and all the preparation talking to my wife, going through and getting excited or otherwise about the prospects of maybe some new solution on the horizon which I’d participate in, to be told suddenly it was all off you obviously feel let down a bit. And so that’s really my experience of that. Since then, though they’ve approached me on others, I have not taken part in any tests with them. Two reasons' one, I, they haven’t really come up with one which really interests me - not on the same subject by the way - but the other one is I’m just you know, I feel a little bit less enthusiastic [laughs] than I was before.

It was typical administration, I thought, if I’m honest with you [laughs].

And did they apologise, or write to you afterwards?

The doctor did. They didn’t write to me, no. I think the doctor was a bit sheepish. That was a woman doctor, she was, had a very nice manner to her, but certainly the admin people didn’t. I was just a number as far as they were concerned. And, you know, I never got a letter back or anything of that nature, no. I just got my expenses paid, or my mileage paid, and just left. Had a cup a tea [laughs].

And the wider implication, as you say, is that longer term this has slightly put you off.

Oh, yes, anything like that has that - you know, you tend to have a bit of a blockage if, certainly if you can’t see a logic to it. And I mean black and white, yes, I can see that they were probably right, but there is such a grey area there that I cannot believe that any logic would have - you know, I just think they were wrong in their judgement call.

Anton has been in several trials and is always keen to take part. He describes how he tries to convince staff to let him join, even if he is not strictly eligible.

Anton is an auditor. He is single. Ethnic background/nationality' Sri Lankan. (You can see more of Anton talking about his experiences of depression on our site on Mental health' ethnic minority experiences, Interview 13).

Sometimes they’ll say to me, “Oh, you’re over 60, you don’t come within our parameters”, then I say, “Oh, please, please, I’m suffering, please, please”. As they know me, I say, “Oh, please give it to me - nothing wrong just giving a tablet. Include me as the odd one out,” [laughs]. Like that, that personal contact helps.

Have you actually managed to persuade people?

Oh yeah, I go along on the charm offensive [laughs].

And they’ve said yes?

Oh, they’ve said yes. Even I’ve tried it on the telephone, when I ring up for trials, they’ll ask me, We want to ask you a few questions.” Then suddenly they said to me, “No, no, no, we are looking for people who are on insulin”. I said, “Oh, doctor, I’m really suffering. You’ll be a great help”. “Since 1988 I’m going through this. Well, please have a little compassion. Well, can I come and see you, at least, you know, at least get a bit of advice?” As soon as they see you, and I put on this sort of sad face [laughs], I said, “Oh, I’ve got to look after my mum” and all these things, and then they will relent, and then they’ll take me on [laughs].

Goodness knows what it does to their results [laughter].

Yeah, that’s right. I prick their conscience and, I may not come under the criteria, look at it like this.” My being an auditor and accountant, I said, “Just imagine, you give me the tablet and I get well, I’m no drain on health services. I can go back and work, I can contribute towards taxes, I could even come and help [laughs].

And sometimes have people said to you, “No, we’re still not giving you the drug because you’re not at the right age, or you’re not on insulin” or whatever?

Yeah. Well, then sometimes they categorically say no. Then I say to them, “In that case could you please put me on the reserve, because if you didn’t get enough participants then you can get in touch with me.” I never give up [laughs], I never give up. I remember in my younger days I used to work for a German multinational, one day when I was walking along the office the sales director called and said to me, “Are you free on such and such a day?” I said, “Yes, why?” “Because five of my salesman are going on this super sales course, and one of them can’t go because of such and such a reason. The course cost about a thousand quid. I don’t want to waste it, we won’t get the money. Although you’re an auditor, maybe you may learn a few things, and go on this course. It’s a one day course, it’s nice in the National Exhibition Centre in Birmingham, have a lovely meal, and have fun and come back.” So when I went to one of those courses, the lecturer or the tutor said to me, “When you go to sell something to somebody and if they said, ‘No, I don’t want it’, don’t take no for an answer. At that time, at that point in the situation they said no, try a different point, then they will say yes. So when even when they categorically say no, I then say, “Oh, please put me on your waiting list.” Then after a week I ring them up. I say, “Do you remember I spoke to you about it?” Then, then they might say, “Oh, yeah. We’ve got enough participants.” Sometimes I have a bit of luck, though, because there’s more than one person is involved in the research. Then when I ring them up I ask who is speaking, then if it was a different person, then I knew what was the critical question in– what do you call - rejecting me. Then I would say, “Oh, no I’m 59”, instead of 60.

Have you ever been found out?

In some cases where they send an application form and they’ll ask age, so instead of putting, 61 or 62, I would put my date of birth and if they are lazy to work it out, well, that is their problem. So later on they’ll find out, “I didn’t lie, I put my date of birth. Oh, I didn’t know.” I’ll play the innocent part [laughter].

FOOTNOTE: It is important to remember that there may not be a trial which is suitable for you. Some exclusion criteria may be there to protect your own safety; others may help to ensure that the trial results will be easier to interpret. If you want to know why you are not eligible for a trial to which you would like to contribute, ask the researchers to explain why you should not participate.

Understandably people looking for a cure may be desperate to take part in a trial. However, it is important to remember that there may not be a trial which is suitable for you. (See also ‘Difficulties finding a trial to join’ and ‘Reasons for taking part – personal benefit’). Some exclusion criteria may be there to protect your own safety; others may help to ensure that the trial results will be easier to interpret. If you want to know why you are not eligible for a trial to which you would like to contribute, ask the researchers to explain why you should not participate.

Danny was nearly excluded from a trial after it was discovered that she would be on holiday abroad when her next appointment was due. Eventually a way round it was found, but she was annoyed that trial staff had not planned ahead to allow for summer holidays. She even wondered how valid the trial was if it only included people with nothing to do all summer.

Danny is a retired teacher, who now does voluntary work with her grandchildren and their schools. She is married with 2 adult children. Ethnic background/nationality' White, mixed ethnicity.

Anyway, then I told him - this trial started in July, I’m sure it was July - and I told him that I was going to France, because as an ex-teacher I still live by school holidays, especially as I’ve got grandchildren and we all go on holiday together. And I said we were going away for a month. Well, that threw them into some degree of apoplexy, and they said, “We might have to exclude you from the trial.” Well, where I come from, in my language exclusion’s bad, you know [laughs]. You get excluded from school for doing bad things. Have I done something bad? Not, “Oh dear, [tut] should have really thought about the summer holidays because there’s going to be a lot of people who might not be able to get up here because they’ve got children to look after, etc etc.” So there is an element of not taking on the wider life. Now, nobody - I mean although I told them I was retired, throughout the trial there was an assumption, a tacit assumption, that I was available. Had they said to me at the outset I could have given them my availabilities, and mine are very flexible. Now, it raised the question with me, are they not random trials? Are they just trials for people [laughs] that can go up there at the drop of a hat, or are retired and sick, or unemployed?

Because that issue was not addressed in the screening that got me there, and so because it wasn’t addressed it became a bit of an issue because I wasn’t available.

But it wasn’t a big deal, so the doctor went and spoke to the senior doctor.

There may be good reasons why someone should not be included in a trial, either for their own health or for the scientific validity of the trial. This should not be taken as a personal rejection. However, Danny explains that, as a former teacher in a disruptive pupil unit, she found the word ‘excluded’ problematic, and felt the way staff talked to her about this could have been more sensitive and helpful. (See also ‘Information, communication and questions’).